Stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Study 1: Inclusion criteria for stroke patients: 1. The subject suffered from unilateral limb paralysis due to the first clinical stroke, with a duration of less than 12 months; 2. The subjects are aged between 18 and 75 years old; 3. Weight= 24 on the Mini Mental State Examination (MMSE); 6. Agree and sign the informed consent form for this clinical study. Inclusion criteria for healthy subjects: 1. Normal vision or corrected to normal; 2. Age between 18 and 75 years old; 3. No gait disorders and no limb injuries; Study 2: Inclusion criteria for stroke patients: 1. The subject suffered from unilateral limb paralysis due to the first clinical stroke, with a duration of less than 12 months; 2. The subjects are aged between 18 and 75 years old; 3. Weight= 24 on the Mini Mental State Examination (MMSE); 6. Agree and sign the informed consent form for this clinical study.
Exclusion criteria
Exclusion criteria: Study 1: Exclusion criteria for stroke patients: 1. Unstable basic vital signs; 2. Lower limb bone and joint tumors, deformities, and lower limb amputations; 3. Severe spinal deformities; 4. Severe osteoporosis; 5. New York College of Cardiology heart function classification >= Grade III; 6. Limited range of motion of lower limb joints and deep vein thrombosis in lower limbs; 7. Serious musculoskeletal disorders that affect lower limb motor function, such as severe persistent joint stiffness; 8. Lower limb fractures do not meet clinical healing standards; 9. Severe spasticity of the lower limbs (modified Ashworth >= 3 grade). Exclusion criteria for healthy subjects: 1. Existence of any neurological or physical illnesses; 2. History of any psychological or psychiatric disorders; 3. Lower limb fractures and surgical history; 4. Subjects who have experienced robot assisted gait. Study 2: Exclusion criteria for stroke patients: 1. Unstable basic vital signs; 2. Lower limb bone and joint tumors, deformities, and lower limb amputations; 3. Severe spinal deformities; 4. Severe osteoporosis; 5. New York College of Cardiology heart function classification >= Grade III; 6. Limited range of motion of lower limb joints and deep vein thrombosis in lower limbs; 7. Serious musculoskeletal disorders that affect lower limb motor function, such as severe persistent joint stiffness; 8. Lower limb fractures do not meet clinical healing standards; 9. Severe spasticity of the lower limbs (modified Ashworth >= 3 grade).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Scale scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| 10 Meter Walk Test scores;Functional Ambulation Category scores;Berg’s Balance Scale scores;6 Minute Walk Test scores;Functional near-infrared spectroscopy outcomes;Surface electromyography outcomes;Three-dimensional motion analysis outcomes; | — |
Countries
China
Contacts
The First Rehabilitation Hospital of Shanghai